ClearanceBrief
510(k) K250313 · KGO Surgeon'S Gloves

Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

ApplicantHarps Europe Manufacturing GmbH, Niederosterreich, AT
DecisionSubstantially Equivalent, Aug 19, 2025
ReceivedFeb 3, 2025
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K250313

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.